FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
K Number: K884413
·
Decision Dec 2, 1988
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
6
Applicant Total
94
Review Days
43
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Basic Information
- Device Name
- CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
- K Number
- K884413
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Valleylab, Inc.
- Date Received
- October 20, 1988
- Decision Date
- December 2, 1988
- Product Code
- LBK
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LBK | Neurosurgical Ultrasonic Instruments | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBK), ordered by most recent decision date.
DISSECTRON PORTABLE UNIT
FDA 510(k)
FDA Unclassified
·Unknown
OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
FDA 510(k)
FDA Unclassified
·Unknown
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
FDA 510(k)
FDA Unclassified
·Unknown
AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT
FDA 510(k)
FDA Unclassified
·Unknown
BOVIE ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
COOPER LASER SONICS CUSA MODEL 200
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Valleylab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | May 29, 2003 | Substantially Equivalent |
| K010010 | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR | Apr 2, 2001 | Substantially Equivalent |
| K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | Mar 26, 2001 | Substantially Equivalent |
| K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | Mar 7, 2000 | Substantially Equivalent |
| K983743 | BISURE LAPAROSCOPIC BIPOLAR FORCEPS | Jan 21, 1999 | Substantially Equivalent |
| K981916 | LIGASURE VESSEL SEALING SYSTEM | Aug 28, 1998 | Substantially Equivalent |
| K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jul 6, 1998 | Substantially Equivalent |
| K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | Jun 29, 1998 | Substantially Equivalent |
| K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH | Mar 28, 1997 | Substantially Equivalent |
| K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM | Mar 11, 1997 | Substantially Equivalent |